German Society for Regulatory Affairs (DGRA)
- § 1 Name, domicile, fiscal year ◢
- § 2 Purpose of the Society ◢
- § 3 Types of membership ◢
- § 4 Acquisition of membership ◢
- § 5 Termination of membership ◢
- § 6 Membership fees ◢
- § 7 Committees of the Society ◢
- § 8 The Board ◢
- § 9 Responsibilities of the Board ◢
- § 10 Term of office of Board ◢
- § 11 Adoption of resolutions by the Board ◢
- § 12 Extended Board ◢
- § 13 The Advisory Board ◢
- § 14 The General Meeting ◢
- § 15 Convocation of the General Meeting ◢
- § 16 Adoption of resolutions by the General Meeting ◢
- § 17 Members' proposals for the agenda ◢
- § 18 Extraordinary General Meetings ◢
- § 19 President ◢
- § 20 Dissolution of the Society ◢
(1) The Society shall bear the name "DGRA - Deutsche Gesellschaft für Regulatorische Angelegenheiten (German Society for Regulatory Affairs)" and is to be entered in the Vereinsregister (register of societies); after registration it shall bear the addendum "e.V." (eingetragener Verein = registered association).
(2) The Society shall be domiciled in Bonn
(3) The Society's fiscal year shall be the calendar year
(1) The Society shall support the course of academic study leading to the title of "Master of Drug Regulatory Affairs" (*). The Society shall promote basic and further training in the field of regulatory affairs.
(2) The Society shall exclusively and directly pursue ends serving the public good as defined in the section entitled "Steuerbegünstigte Zwecke" (tax-privileged purposes) of the Abgabenordnung (German fiscal code).
The purpose as defined in these Articles of Association shall be realised in particular by means of the following measures:
Regular basic and further training courses in the following specialised areas:
- Definition of and description of tasks associated with regulatory affairs
- Information management
- Pharmaceutical law
- Quality management
- Pharmaceutical technical documentation
- Pharmacotoxicological documentation
- Clinical documentation
- Marketing authorisation – national (Germany)
- Marketing authorisation – international
- Acquisition of marketing authorisation
- Acquisition of marketing authorisation
- Decision analytics
Procurement, preparation and communication of scientific information dealing with regulatory affairs
Publication and discussion of this information in the electronic and other media;
Communication with regulatory authorities at national and international level.
(3) The Society shall operate on a disinterested basis; it shall not primarily pursue profitable ends.
(4) Funds of the Society must only be used for purposes in accordance with the Articles of Association. Members shall receive no profit share nor any other financial benefits out of the Society's funds. No individual shall be favoured by expenditure that is alien to the purpose of the Society or by unwarrantedly high compensation.
(5) On dissolution of the Society or discontinuation of its current purpose, its assets shall fall to the Deutsche Forschungsgemeinschaft - DFG – (German Research Society), which shall employ them to support and advance young scientists.
(6) Any resolution to amend these Articles of Association shall be submitted to the relevant tax authority prior to its notification to the Registration Court.
(*) Formerly "Expert for Regulatory Affairs", altered in the official notification of the Rheinische-Friedrich-Wilhelms University, Bonn – notification bulletin - dated 17 January 2001.
(1) Members of the Society shall fall into the categories full member, subscribing member and honorary member.
(2) Full members shall be those members who participate in the Society's work in order to actively promote the DGRA's goals or assume a function in its administration. Subscribing members support the Society's work primarily by paying an increased membership fee.
(3) Honorary members are individuals who are appointed as such in acknowledgement of their particular merits and service to society.
(1) All physical and juridical persons who have attained their majority can become members of the Society. The Board shall decide on the acceptance of written applications.
(2) Honorary members shall be appointed by the General Meeting on suggestion of the Advisory Board with a majority of 2/3 of the voting members. The appointment can be revoked again in the same manner.
(1) Membership shall cease to exist through death, resignation, striking from the list of members or exclusion from the Society.
(2) Resignation shall be notified to the Board in writing. Resignation shall only be permissible at the end of a calendar year and with observation of a period of notice of 3 months.
(3) A member can be struck off the list of members by resolution of the Board if he or she is in arrears with the payment of his or her membership fee in spite of having twice received a dunning letter at the address last notified to the Society. The striking off the list cannot be resolved until 3 months have lapsed since dispatch of the second dunning letter and the fees owed have still not been paid up. The member shall be notified that his or her name has been struck off the list.
(4) A member can be excluded from the Society by resolution of the Board if he or she has committed a serious offence against the interests of the Society. Prior to expulsion the member shall be granted an opportunity to state his or her position within a reasonable period of time.
(1) Members shall be charged membership fees. The amount of the annual fees and their due date shall be determined by resolution of the General Meeting on proposal of the Board. A ruling on fees can be issued in like manner.
(2) Honorary members shall be exempt from the payment of fees.
The committees of the Society shall be the Board, the Advisory Board and the General Meeting.
(1) The Board of the Society shall consist of 5 persons, the Chairperson, the Deputy Chairperson, the Officer in charge of training, the Treasurer and the Secretary.
(2) The Society shall be represented in and out of court by two members of the Board, one of whom shall be either the Chairperson or the Deputy Chairperson.
(1) The Board shall be responsible for the management of the Society. It shall be responsible for all business of the Society that is not assigned to a different committee of the Society. Its principal duties shall be:
- Preparation of the General Meeting and the Agenda
- Convocation of the General Meeting
- Execution of the General Meeting's resolutions
- Preparation of a budget for each fiscal year accounting preparation of the Annual Report
- Conclusion and termination of employment contracts
- Resolutions on the acceptance, striking off and exclusion of members.
(2) The Board is obliged to consult the Advisory Board on all important matters.
The Board shall be elected by the General Meeting for a term of 4 years, starting from the date of the election; however, it shall remain in office up until a new Board is elected. Each Board member shall be elected individually. Only full members shall be eligible for election. If a member of the Board leaves the Society during his or her term of office, the Board shall elect a substitute member for the remainder of the departing member's term.
(1) As a rule the Board shall adopt resolutions at Board meetings that are convened by the Chairperson, or, if the Chairperson is prevented from attending, by the Deputy Chairperson, in writing or by facsimile. Meetings shall be convened with at least one week's notice. The agenda need not be notified. The Board shall decide by simple majority. In the event of a tied vote the Chairperson or person leading the meeting shall have the casting vote.
(2) It shall not be necessary to convene a Board meeting if all Board members approve, in writing, a proposal or a resolution. Board meetings shall be led by the Chairperson, or in the event of the latter's being prevented from attending, by the Deputy Chairperson. For the purposes of furnishing evidence the Board's resolutions shall be entered in a resolution book and the entry signed by the person leading the meeting. The entry shall include the place and time of the meeting, the names of the participants, the resolutions adopted and the voting results.
(1) The extended Board shall consist of two cash auditors and, if appointed, one in-house lawyer.
(2) The in-house lawyer shall be appointed by the Board as required.
(3) The two cash auditors shall be elected by the General Meeting on the Board's proposal.
(1) The members of the Advisory Board shall be appointed by Board resolution with a 2/3 majority. Members shall have a right to propose candidates. The Advisory Board shall comprise at least four full members, while further members can be nominated by the subscribing members, each subscribing member being entitled to nominate one physical person.
(2) The Advisory Board's purpose is to advise the Board on important Society business. It shall propose candidates for appointment as honorary members (Article 4 para. 2).
(3) Advisory Board meetings shall take place at least once per fiscal year. The Advisory Board shall be convoked by the Chairperson or his or her Deputy with at least one week's prior notice. The agenda need not be notified. The Advisory Board must be convoked if at least four Advisory Board members request its convocation from the Board in writing. If the Board fails to comply with this request within a period of two weeks, the Advisory Board members who requested the convocation of the Advisory Board shall be entitled to convoke it themselves.
(4) All Board members shall be entitled to attend the meetings of the Advisory Board as well as to participate in discussions. However, they shall not possess any voting rights. Board members shall be notified in writing and in advance of the Advisory Board meetings.
(5) The meetings of the Advisory Board shall be led by the Chairperson (Article 8 para. 1), or in the event of the latter's being prevented from attending, by the Deputy Chairperson. In other cases those Advisory Board members that have convened shall determine which person shall lead the meeting.
(6) The Advisory Board shall form its opinion through the adoption of resolutions with a majority of the valid votes cast.
(7) For the purpose of furnishing evidence the Advisory Board's resolutions shall be entered in a resolution book and the entry signed by the person leading the meeting. The Society's members shall be informed in a suitable manner of the essential content of the Advisory Board meetings.
(1) Each member – including honorary members – shall have one vote.
(2) The General Meeting shall be exclusively responsible for the following matters:
- Approval of the budget prepared by the Board for the following fiscal year receipt of the Board's Annual Report discharge of the Board
- Election and dismissal of members of the Board
- Adoption of resolutions concerning the amendment of the Society's Articles of Association and the dissolution of the Society as well as the amount of the membership fees and the ruling on fees
- Appointment of honorary members
- Recommendations to the Board.
Annual General Meetings shall take place at least once a year – whenever possible in the last quarter. The Board shall convoke the AGM in writing 4 weeks in advance, indicating the agenda. The four-week period shall commence on the day following dispatch of the letter of invitation. The letter of invitation shall be deemed to have been received by the member if it is addressed to the member's last address notified to the Society in writing. The agenda shall be determined by the Board.
(1) The General Meeting shall be led by the Chairperson, or, if the Chairperson is prevented from attending, by the Deputy Chairperson or other Board member. If no Board member is present, the General Meeting shall determine a person to lead the meeting.
(2) The Secretary shall keep the minutes of the General Meeting. In the event of his or her absence, the General Meeting shall determine another person to keep the minutes.
(3) The General Meeting shall not be public. Its chairperson can authorise guests to attend. The General Meeting shall decide on the admittance of the press, radio and television.
(4) The General Meeting shall form a quorum regardless of the number of members present if it has been duly convened. This shall not apply to resolutions serving to amend the Articles of Association and to resolutions on the dissolution of the Society; any such resolutions shall require the presence of 1/10 of all members of the Society. In the absence of a quorum, the Board is obliged to bring about written voting from all members of the Society on the subject matter of resolution within 4 weeks. In this written voting the General Meeting shall form a quorum at all events. Reference must be made to this in the invitation.
(5) The resolutions of the General Meeting shall be passed by simple majority of votes cast insofar as nothing to the contrary is determined by the Articles of Association or compelling law.
(6) Amendment of the Articles of Association shall require a 2/3 majority of the votes cast, dissolution of the Society a 3/4 majority of the votes cast.
(7) The absolute majority of votes shall be required to elect members of the Board. Abstentions shall be viewed to be uncast votes. If neither of the candidates achieves the absolute majority, a second ballot must immediately be conducted between the two candidates with the highest number of votes. The candidate shall be successful in the second ballot who receives the most votes.
(8) Resolutions concerning the dissolution of the Society and amendments to the Articles of Association can only be adopted under the agenda.
Every member may, no later than one week prior to the date of the General Meeting, submit a written request to the Board that further matters be added to the agenda. Requests concerning the amendment of the Articles of Association must be submitted to the Board no later than two weeks prior to the date of the General Meeting. The General Meeting shall decide on the adoption of additional agenda items at the beginning of the meeting.
Extraordinary General Meetings must be convoked when this lies in the interests of the Society or if requested of the Board in writing by 1/10 of all members, stating the purpose and reasons. The Extraordinary General Meeting shall be subject to the same regulations as the Annual General Meeting, with the appropriate changes. The period of notice can be shortened to one week.
The Board can nominate an internationally acclaimed personality as President and release him or her from responsibility. The President shall advise the Board on the execution of its transactions and represent the Society in public. The President shall be an honorary member of the Society.
Dissolution of the Society can only be resolved in a General Meeting and with a ¾ majority of the votes cast. Article 16 para. 4 shall apply with respect to the presence of a quorum.